Congress, industry call on FDA to ban DMBA from sports nutrition supplements

WASHINGTON — Congress and the sports nutrition industry independently called upon the Food and Drug Administration on Wednesday to act on removing an untested synthetic stimulant that was found in 12 products marketed as sports nutrition supplements, according to research published online yesterday by the journal Drug Testing and Analysis.

 

"A synthetic stimulant never before studied in humans, 1,3-dimethylbutylamine (DMBA), was suspected of being present in dietary supplements," noted lead researcher Pieter Cohen, of Harvard Medical School. "DMBA is an analogue of the pharmaceutical stimulant, 1,3-dimethylamylamine (DMAA), which was recently banned by the U.S. Food and Drug Administration," he wrote. "The stimulant has never been studied in humans; its efficacy and safety are entirely unknown. Regulatory agencies should act expeditiously to warn consumers and remove DMBA from all dietary supplements."

 

“We agree with the authors of this analysis that DMBA is an illegal dietary ingredient and therefore should not be used in dietary supplements," stated Steve Mister, president and CEO for the Council for Responsible Nutrition. "In fact, last month, CRN formally requested that the Food and Drug Administration investigate the regulatory status of this ingredient, marketed as Amp or Amp Citrate," he said. "Further, we urged the agency to consider the potential dangers of this product, given it is a similar substance, in chemical structure and in effect, to DMAA, an ingredient already prohibited by FDA from use in dietary supplements."

 

Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn., also called the agency to task in banning this ingredient. "We call on FDA to take action against products containing DMBA," the senators wrote. "We believe products containing DMBA are adulterated and/or misbranded, and the FDA has a responsibility ... to take action against the manufacturers of such products."

 

According to a USA Today report published Thursday morning, GNC has stopped selling supplements containing DMBA as of Wednesday.